CLINICAL TRIALS PROFILE FOR ENHERTU

All Clinical Trials for ENHERTU

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03523572 ↗	Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer	Active, not recruiting	AstraZeneca	Phase 1	2018-06-20	This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: - Part 1 is to identify the recommended dose to use for treatment. - Part 2 is to find out how well the combination works, and how safe and tolerable it is.
NCT03523572 ↗	Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer	Active, not recruiting	Bristol-Myers Squibb	Phase 1	2018-06-20	This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: - Part 1 is to identify the recommended dose to use for treatment. - Part 2 is to find out how well the combination works, and how safe and tolerable it is.
NCT03523572 ↗	Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer	Active, not recruiting	Daiichi Sankyo, Inc.	Phase 1	2018-06-20	This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: - Part 1 is to identify the recommended dose to use for treatment. - Part 2 is to find out how well the combination works, and how safe and tolerable it is.
NCT04553770 ↗	Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer	Recruiting	Daiichi Sankyo Co., Ltd.	Phase 2	2020-10-09	This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.
NCT04553770 ↗	Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer	Recruiting	Translational Research in Oncology-U.S	Phase 2	2020-10-09	This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.

Clinical Trial Conditions for ENHERTU

Condition Name

Condition Name for ENHERTU
Intervention	Trials
Metastatic Breast Cancer	4
HER2-positive Breast Cancer	4
Unresectable Malignant Solid Neoplasm	3
Breast Cancer	3

Condition MeSH

Condition MeSH for ENHERTU
Intervention	Trials
Breast Neoplasms	11
Neoplasms	5
Carcinoma, Non-Small-Cell Lung	4
Stomach Neoplasms	3

Clinical Trial Locations for ENHERTU

Trials by Country

Trials by Country for ENHERTU
Location	Trials
United States	70
Spain	10
Germany	10
United Kingdom	7
Canada	6

Trials by US State

Trials by US State for ENHERTU
Location	Trials
New York	6
California	6
Massachusetts	5
Florida	5
Virginia	3

Clinical Trial Progress for ENHERTU

Clinical Trial Phase

Clinical Trial Phase for ENHERTU
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	3
Phase 3	1

Clinical Trial Status

Clinical Trial Status for ENHERTU
Clinical Trial Phase	Trials
Recruiting	11
Not yet recruiting	9
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for ENHERTU

Sponsor Name

Sponsor Name for ENHERTU
Sponsor	Trials
AstraZeneca	8
Daiichi Sankyo, Inc.	4
Daiichi Sankyo	4

Sponsor Type

Sponsor Type for ENHERTU
Sponsor	Trials
Industry	26
Other	19
NIH	3

Clinical Trials Update, Market Analysis, and Projection for ENHERTU (Fam-Trastuzumab Deruxtecan)

Last updated: April 1, 2026

What is the current status of ENHERTU’s clinical development?

ENHERTU (fam-trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) targeting HER2-expressing cancers. Its clinical development encompasses multiple indications with extensive trials completed and ongoing.

Completed Clinical Trials

• HER2-positive metastatic breast cancer (mBC): Phase 2 DESTINY-Breast01 demonstrated a 60% overall response rate (ORR). FDA approval followed in December 2019 for this indication.
• HER2-low breast cancer: Phase 3 DESTINY-Breast04 showed improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy, with a notable ORR of 52.6% among HER2-low patients.
• Non-small cell lung cancer (NSCLC): Phase 2 DESTINY-Lung01 reported an ORR of 55%, with ongoing Phase 3 trials.
• Gastric and gastroesophageal junction cancers: Phase 2 DESTINY-Gastric01 exhibited an ORR of 40% in HER2-positive gastric cancers. Phase 3 trials are in progress.

Ongoing Clinical Trials

• DESTINY-Breast03 (HER2-positive mBC): Tested compare ENHERTU to trastuzumab emtansine (Kadcyla). Expected final data in 2023.
• DESTINY-Lung02: Evaluates efficacy in HER2-mutant NSCLC.
• Other indications: Trials include colon cancer and biliary tract cancers, aiming to expand the drug’s label.

What is the competitive landscape for ENHERTU?

Key Competitors

Drug	Indication	Mechanism	FDA Approval	Market Launch	Key Data
Kadcyla (trastuzumab emtansine)	HER2-positive breast cancer	ADC	2013	Marketed	ORR ~39% in mBC
Enhertu (fam-trastuzumab deruxtecan)	HER2-positive and HER2-low cancers	ADC	2019 (US), 2021 (EU)	Marketed	ORR 60%-55% in clinical trials
Zynlonta (loncastuximab tesirine)	Lymphomas	ADC	2021	Marketed	ORR ~48% in DLBCL

ENHERTU’s unique payload and high drug-to-antibody ratio (8:1) distinguish it from competitors like Kadcyla, which has a 3.6:1 ratio.

What are the market dynamics and growth prospects?

Market Size and Revenue Estimates

• HER2-positive breast cancer: Global market expected to reach USD 3.2 billion by 2027, growing at a compound annual growth rate (CAGR) of 7%. ENHERTU’s share is increasing following FDA approvals and positive trial outcomes.
• HER2-low breast cancer: Estimated USD 2.9 billion market by 2026, driven by higher prevalence due to improved diagnostic criteria.
• Gastric and NSCLC indications: Smaller markets but growing, with estimated cumulative revenues around USD 1.5 billion globally over the next five years.

Regulatory Approvals and Launches

• US: FDA approved ENHERTU for HER2-positive mBC in December 2019, with subsequent approvals in EU and Japan.
• Europe: Approval in HER2-positive gastric cancer in March 2021.
• Japan: Multiple approvals across oncology indications since 2020.

Commercial Challenges

• Toxicity management: Interstitial lung disease (ILD) presents safety concerns, requiring careful monitoring.
• Reimbursement: Achieved in multiple markets but varies by healthcare system.
• Market penetration: Competition with HER2-targeted therapies and emerging ADCs.

What is the projected growth trajectory?

Short-term (2023-2025)

• Rapid sales growth driven by expanding indications, especially HER2-low breast cancer.
• Expected sales CAGR of approximately 35% based on trial success and approval pipeline.
• Critical milestone: Data from DESTINY-Breast03 to validate switch therapy potential.

Long-term (2026-2030)

• Potential new indications: gastric, lung, colon, biliary tract cancers.
• Overall market share forecast at 15% of HER2-targeted ADC market.
• Revenue projections suggest exceeding USD 8 billion globally by 2030 with premium pricing and expanded indications.

Key Takeaways

• ENHERTU remains a leading HER2-targeted ADC with pivotal indications for breast, gastric, and lung cancers.
• Ongoing Phase 3 trials could expand its label and drive substantial revenue growth.
• Competition from Kadcyla, Zynlonta, and emerging ADCs necessitates strategic market positioning.
• Safety management and reimbursement policies are critical factors influencing adoption.
• The drug’s adoption hinges on data from DESTINY-Breast03 and other pivotal trials to confirm efficacy in broader populations.

FAQs

1. When was ENHERTU approved for metastatic breast cancer?
   December 2019 by the FDA.

2. What distinguishes ENHERTU from other HER2-targeted ADCs?
   Its high drug-to-antibody ratio (8:1) and potent payload contribute to higher efficacy.

3. What safety concerns are associated with ENHERTU?
   Interstitial lung disease (ILD) is a primary safety risk, requiring regular monitoring.

4. What markets have approved ENHERTU?
   US, EU, and Japan have approved it for various HER2-positive and HER2-low cancers.

5. What is the outlook for ENHERTU sales?
   Projected to exceed USD 8 billion globally by 2030, driven by pipeline expansion and indication approvals.

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References

1. U.S. Food and Drug Administration. (2019). FDA approves Enhertu for metastatic HER2-positive breast cancer. [FDA press release].
2. European Medicines Agency. (2021). Enhertu (trastuzumab deruxtecan) — Summary of opinion.
3. Destinysite. (2022). DESTINY-Breast04 trial results. Journal of Clinical Oncology.
4. MarketResearchFuture. (2022). HER2-targeted therapies market analysis.
5. Global Data. (2022). Oncology ADC therapeutic landscape.